At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3 enrolled
Drug / intervention
Pegzilarginasedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Open-Label Study of Safety, Pharmacokinetics, and Activity of Weekly Subcutaneous Pegzilarginase in Subjects <24 Months Old With Arginase 1 Deficiency
In Brief
A Phase 3 clinical trial evaluating Pegzilarginase for Arginase 1 Deficiency. Completed, enrolled 3 participants across 3 sites in 3 countries.
Detailed Summary
This is an open-label, multicentre study to evaluate the safety, PK, and activity (PD) of weekly subcutaneous (SC) administration of pegzilarginase in subjects with ARG1-D who are \< 24 months of age. The study consists of a screening period of up to 4 weeks, a subsequent 12-week treatment period, and a safety follow-up period of 8 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArginase 1 Deficiency
CountriesAustria, Portugal, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20252026
Enrollment StartAug 2024
First PostedSep 2024
Primary CompletionJun 2025
TodayJul 2026
First PostedSep 3, 2024
Enrollment StartAug 30, 2024
Primary CompletionJun 17, 2025
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 1.8 years ago
Interventions
Pegzilarginasedrug
SC administration of pegzilarginase over 12 weeks in subjects with ARG1-D who are \< 24 months of age